New Clinical Trial with Armored CAR T-cells

Chimeric Antigen Receptor (CAR) T-cell therapy uses a patient’s own immune cells (T-cells) and modifies them in a lab so they are better at finding and eliminating cancer cells. CAR T-cells are engineered to carry a receptor that binds to a specific protein on cancer cells, like CD19, a protein commonly found in certain blood cancers.

CAR T-cell Therapy is Continuously Being Improved

CAR T-cell is groundbreaking for treating cancer because it uses modified healthy immune cells to eliminate cancer cells. Although its use has good responses, the downside is that side effects like cytokine release syndrome, nervous system side effects, and depletion of CAR-T cells (running out of cells), demand further treatment advancements to create improved CAR T-cells that bind only to cancer cells and last longer in the body, minimizing as much as possible the side effects. 

Thanks to research, there is more than one CAR-T cell option, depending on what they were designed to do and the proteins they link to. That’s why CAR T-cell therapy is currently one of the most active areas in research, always looking for improvement. 

New Clinical Trial Testing Armored CAR T-Cells

A new Phase I clinical trial is now recruiting patients to test a genetically engineered type of CAR T-cell therapy, known as EGFRt/19-28z/IL-12 CAR T-cells, for people with blood cancers that express CD19 and whose cancer came back after treatment (relapsed) or didn’t respond to other therapies (refractory).

What are Armored CAR T-cells? 

These armored CAR T-cells target the CD19 protein found on lymphoma cells, and they also have a protein called interleukin-2 (IL-2), which works as an immune system booster (cytokine). Combined, they improve the immune system against cancer and enhance the T-cells' ability to survive and function for longer.

What is the Purpose of the Trial?

The trial seeks to determine the safety, side effects, and best dose of the armored CAR T-cells. The investigators want to find out if, when adding the gene for IL-12, the modified T-cells may fight cancer cells more effectively and improve the overall immune response.

Who Can Join the Trial?

The trial NCT06343376 includes people who previously received CAR T-cell therapy targeting CD19 but need further treatment. This trial includes patients with the following blood cancers that are CD19 positive:

• Diffuse large B-cell lymphoma (DLBCL)

• High-grade B-cell lymphoma (HGBL)

• Chronic lymphocytic leukemia (CLL)

• Mantle cell lymphoma

• Follicular lymphoma

Visit the trial page for more information on eligibility criteria.

What is the Clinical Trial Plan? 

All the patients who participate in this trial will first undergo a procedure called leukapheresis, where their T-cells are collected. Then, depending on the group they are assigned to, they will receive either:

• EGFRt/19-28z/IL-12 armored CAR T-cells alone, or

• A combination of chemotherapy (cyclophosphamide and fludarabine) followed by the armored CAR T-cells.

Throughout the trial, various tests will monitor the participants’ health and will consist of heart ultrasound, imaging (PET or CT scans), and bone marrow biopsies, to observe their response to the treatment.

After treatment, patients will be closely monitored for side effects and signs of cancer reappearance, with follow-ups occurring over several months and up to 5 years or for as long as each patient agrees to,  to assess long-term safety and effectiveness.

Why is This Clinical Trial Important?  

This trial represents an exciting new step in CAR T-cell therapy, potentially offering a more effective treatment option for blood cancer patients. By enhancing T-cell function through the addition of IL-12, researchers hope to improve outcomes for patients who have limited options left. If you want to learn more or participate in this trial, it is important to discuss the risks and benefits with your healthcare provider.

If you’re interested in looking for more clinical trials, access HealthTree’s Clinical Trial Finder for free! 

Sources: 

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9650233/ 

• https://physicianresources.roswellpark.org/news/next-generation-armored-car-t-cell-therapy-trial-now-open

• https://www.clinicaltrials.gov/study/NCT06343376

• https://pubmed.ncbi.nlm.nih.gov/27068948/